Friend of the court
The judge in the combined Nicopure Labs/Right to be Smoke-Free Coalition lawsuit has some new facts to consider. Two amicus curiae briefs were filed last week, supporting the vaping industry’s challenge to the FDA deeming regulations. The briefs were accepted by Judge Amy Berman Jackson, who is presiding over the suit in the US District Court for Washington, DC.
The court accepted briefs from the Smoke-Free Alternatives Trade Association (SFATA), and a combined brief from TechFreedom and the National Center for Public Policy Research (NCPPR). SFATA is the oldest vapor industry trade group. TechFreedom is a libertarian think tank that opposes regulatory overreach in the technology sector. The NCPPR is a conservative think tank, known best to vapers because of its risk analysis director Jeff Stier, a longtime advocate of tobacco harm reduction and frequent commenter on the FDA’s.
A brief from the Vape A Vet Project supporting the challenge has also been approved and will be filed soon. So will one from the Campaign for Tobacco-Free Kids, which will be in support of the FDA and the deeming regulations.
Amicus curiae is Latin for “friend of the court,” and an amicus brief is an advisory opinion given to the court from a source that is not a party to the case being decided. According to Ronald Standler, an amicus brief “provides the judges with new information or a different perspective from what the parties provided to the judge.”
There will be no market left
The SFATA brief focuses on the compliance costs of the deeming rule, and argues that the burden of completing Premarket Tobacco Applications (PMTA) will be far greater than small- and medium-sized vapor companies can bear. They explain that the regulations will inhibit innovation and “will destroy the vapor industry as it is currently constituted.”
SFATA survey respondents reported mean sales revenue of just $307,200 per year. Over half of vape shop revenue comes from e-Liquid sales, and many SFATA survey respondents reported that one of their top-five (5) revenue generators is sale of their own “in-house” e-Liquid formulations. Even assuming moderate PMTA costs (i.e., $1.09 million), regulatory approval for a single e-Liquid formulation would cost more than three times what the typical industry participant makes in yearly revenues. For example, it would cost The Vapor Bar, discussed supra at Page 3, an astonishing $531.92 million to obtain regulatory approval for all e-Liquids in its store catalog at that moderate PMTA cost. And even aside from the money, such a small company could never perform the original testing and research necessary to secure regulatory approval within two years of the Deeming Rule taking effect. Thus, all but the largest industry participants will cease making e-Liquids, and those few that remain will be able to offer far fewer options. And it seems beyond dispute that, at a cost of $1.68 million for a PMTA for every device, there will be no market left for small producers of equipment.
Direct conflict with the standard required by Congress
The TechFreedom/NCCPA brief attacks the FDA’s ignorance and misinterpretation of scientific evidence and its misapplication of the precautionary principle. How, they ask, can the FDA severely restrict a product that scientific consensus shows is far safer than combustible tobacco?
The FDA’s Deeming Rule fails to consider the scientific evidence readily available to the agency regarding the safety and the public health benefits of e-cigarettes. The Deeming Rule is improper under the APA not merely because it fails any manner of scientific analysis, and is therefore arbitrary and capricious, but also because it is in direct conflict with Congress’s intent
to prevent smoking and aid cessation through the Act.
“Instead of developing science-based standards which would reduce harm, the FDA directly admitted it didn’t understand or evaluate the potential benefits or harms of e-cigarettes,” said Jeff Stier in a press release. “Without that science, it relied on the ‘precautionary principle’ standard, in direct conflict with the evidence-based standard required by Congress.”
“Regulations should be promulgated within the constraints of the rule of law, sound policy, and proportionality,” said Daniel Suraci, an attorney working pro bono on behalf of the National Center for Public Policy Research. “The FDA’s heavy-handed approach to e-cigarettes is an affront to smart governance as the regulations are in direct contradiction of the scientific evidence showing the public health benefits of vaping, and push the public back to cancer-causing tobacco products.”